The Medical Excellence Manager is responsible for managing Investigator Sponsored Studies (ISS), Managed Access Programs (MAP) and Post Trial Access (PTA) Programs. Key responsibilities include:
- Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to stakeholders.
- Manage the MAP/PTA review and approval process, including coordination of case reviews, decision documentation, and communication with relevant parties.
- Serve as the global point of contact for ISS and MAP management for designated products, working with cross-functional internal and external stakeholders.
- Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions with relevant documentation.
- Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating with legal, MPL, and other functions as required.
- Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs
- Provide regular status updates on ISS and MAP/PTA programs to responsible teams and leadership.
- Monitor milestone payments and report ISS budget to budget owners.
- Coordinate with vendors on the set-up and management of MAP and PTA programs as needed.
- A university degree in Life Sciences or Health Sciences, demonstrating a strong academic foundation in the field.
- A minimum of two years' experience within a pharmaceutical company with experience in Medical Affairs
- Comprehensive knowledge of the Investigator Sponsored Studies (ISS) and clinical study processes
- Proven experience in handling managed access or early access programs
- Superior project management skills, including excellent ability to negotiate effectively and resolve conflicts
- Exceptional analytical and problem-solving abilities, coupled with a robust customer-oriented mindset, strong individual initiative, superior organizational skills, and the ability to effectively multitask in a demanding environment.
- Highly developed interpersonal skills, coupled with a communicative and adaptable approach, essential for working with diverse stakeholders.
The base salary range for this role is 120,000 – 145,000 USD. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com